Millions of sleep apnea machines are still recalled. What should patients do now?
A year after a massive recall affecting millions of Philips sleep apnea machines, people are still waiting for replacements or repairs. Some are using the machines in spite of the health risks that got them recalled in the first place.
Philips Respironics issued a voluntary worldwide recall for millions of machines last June because of possible health risks related to noise-abatement foam inside them. The foam can degrade and release possible cancer-causing particles, the Food and Drug Administration says.
The company recommends that people talk to their health care provider to decide what to do next, which the company says could include: Stopping use of the device, continuing to use the recalled machine if your doctor decides the benefits outweigh the risks the company identified in the recall notification, using a similar machine not affected by the recall, or trying alternative treatments.
Model names and numbers for the recalled devices can be found on the FDA’s website. Philips said it sent letters to users with instructions for registering devices to have them repaired or replaced. Recall information and updates are on the Philips website. You can also call 877-907-7508.
Your health care provider can recommend alternative therapy to consider, such as oral appliances or positional therapy — sleeping on your side.
The American Academy of Sleep Medicine says your doctor can help you assess the risk involved in continuing to use the machine versus what you risk by not using a breathing device at all.
Philips has identified the possible health risks of using the recalled machines: airway inflammation; chest pressure; coughing; asthma; skin, eye, and respiratory tract irritation; headaches, sinus infection and toxic carcinogenic effects.
But left uncontrolled, sleep apnea can lead to other health problems, including type 2 diabetes, strokes and heart attacks.
The academy has advised its members to prescribe devices not affected by the recall. But those can be hard to come by.
If that’s not an option for a patient, or another device is unavailable, then doctors should consider comorbidities, severity of symptoms and the risks involved in stopping the therapy, the academy advises.
It also recommends that physicians consider behavioral strategies to mitigate sleep apnea symptoms, such as weight loss, exercise and avoiding alcohol.
“The ultimate judgment regarding any specific care must be made by the treating clinician and the patient, taking into consideration the individual circumstances of the patient, available treatment options and resources,” the academy says.
Users venting in online support groups are angry that their machines have not been replaced or repaired yet.
“Even though Philips’ recommendation is to stop using the equipment, there are no currently available replacement filters or other ‘quick fixes,’” says an explanation on The University of Kansas Health System website.
KU advises patients to contact their medical equipment provider for alternatives.
”Some medical equipment companies may be able to replace a unit with another unit not on the recall list, but this may be unlikely because this recall affects many patients,” the health system says.
You can also call your insurance provider and ask if they’ll pay for a new machine, though some people have had no luck with that.
